Safety advice on particular drugs or classes of drugs
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| Updates on the use of Diane 35 and generics |
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1. European Union: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - Pharmacovigilance Risk Assessment Committee recommendation endorsed by Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels). These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed. Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives. Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism. The risk of thromboembolism occurring with these medicines is low and well known. However, to minimise this risk, further measures should be implemented in addition to the updated product information. These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001801.jsp&mid=WC0b01ac058004d5c1
2. The United Kingdom: MHRA responds to European Medicines Agency review on Dianette
Dr Sarah Branch, the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Deputy Director for Vigilance and Risk Management of Medicines, said “The European Medicines Agency (EMA) has finished its review of the safety of Diane 35 – known as Dianette in the UK - and its generics and has concluded that the benefits continue to outweigh the risks, which are already well known. “In the UK, Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive undesirable hair in women. The review by the EMA found that the risk of venous thromboembolism (blood clots) is rare but it remains an important side-effect for healthcare professionals to monitor and women to be aware of. Our advice is that there is no need for a woman who is feeling well to stop taking her medicine. If any woman has questions about her treatment she should contact her doctor."
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON282763
3. Australia: Cyproterone: Products containing cyproterone with ethinyloestradiol, such as Diane-35: the medicine's benefits continue to outweigh the risks when used for the indications approved by the TGA
On 5 February 2013, the Therapeutic Goods Administration (TGA) published a safety advisory regarding Diane-35 (a combination product containing cyproterone acetate 2 mg with ethinyloestradiol 35 micrograms). This safety advisory included information about the increased risk of venous thromboembolism (VTE). The TGA has since completed a review of the safety information available for products containing cyproterone with ethinyloestradiol. The review has found that there is an increased risk of VTE in women using these products. However, it has been determined that the medicine's benefits continue to outweigh the risks when used for the indications approved by the TGA and outlined in the Product Information (PI). Health professionals and consumers are reminded that products containing cyproterone with ethinyloestradiol should be used with caution in patients who have risk factors for VTE. The TGA will continue to monitor this medicine and is working with the sponsor of Diane-35 to update the PI.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-diane-35-130205.htm#Additional
In Hong Kong, Diane-35 Tab (HK-43330) is registered by Bayer Healthcare Ltd and there are other nine generic products with same ingredients registered in Hong Kong. All are prescription-only medicines and have package inserts including precaution of blood clot. Related news has been released by the EMA, Health Canada and TGA, and was posted on the Drug Office website on 31 January, 1 February, 6 February, 9 February and 18 May 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 31 January 2013. As reported on 18 May 2013, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Department of Health will keep vigilant on any safety updates of the drug and actions taken by other overseas regulatory authorities.
Ends/ Friday, May 31, 2013
Issued at HKT 15:30 |
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